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1 B i o s o l u t i o n s Implementation of pharmatracker TM : A case study Prepared by Ocimum Biosolutions

2 Ocimumbio Solutions August 2006 All rights reserved. 2 B i o s o l u t i o n s an ISO 9001:2000 company Phone US: UK: Germany: India: Fax US: UK: Germany: India: Website:

3 Customer Overview... 4 Challenges of the Customer... 4 Why Ocimum Pharmatracker?... 5 contents Customized Pharmatracker

4 Implementation of Pharmatracker : A Case Study Customer Overview The customer has core competencies in organic chemical synthesis, material characterization, and product formulation. The customer is specialized in supplying materials for forensic drug testing, environmental analysis, custom chemical synthesis, high quality isotope labeled and native standard solutions suitable for drug testing, forensic analysis, calibration preparation, isotope dilution methods, and pharmaceutical analysis. With 32,000 square feet of state-of-the-art facility, they do large scale batch production and testing of formulated and custom synthesis products for environmental, pharmaceutical, forensic, and analytical reference materials. Challenges of the Customer To achieve high level of quality in all units of organization, it was decided to implement a integrated information system to handle challenges of the company. Major challenges were identified in the following areas: Handling large volumes of data To keep track of raw material inventory Automating processes with help of work flow mapping tools Scheduling of tasks, instruments, labs Managing concurrent batches of production Developing QA/QC tools to flag anomaly in the process 4 Collecting data from instruments

5 Automating experimental data analysis Tracking intermediates and finished product inventory Generating various kinds of Certificate of Analysis reports Achieving regulatory compliance processes in place Managing the accessibility of the data with proper security measures Why Ocimum Pharmatracker? After an extensive evaluation of various options available, Ocimum Pharmatracker emerged as the best fit to meet their requirements and the budget. Ocimum demonstrated Pharmatracker capabilities and was able to map 70-80% of the customer s requirements. We have taken their live data and mapped into the product with ease to demonstrate the rich functionality of Pharmatracker. Ocimum was selected because it addressed both customer s product and corporate considerations. To have a completely seamless integration of different components of organization into the platform, some customization was necessary. Keeping this in mind, customer and Ocimum worked in a JAD (Joint Application Development) environment to customize Pharmatracker to customer s requirements. Customized Pharmatracker Ocimum provided comprehensive Inventory Management which allows the customer to manage inventory details for formulated products, raw materials, reagents and standards. Ocimum developed robust instrument management system, which allows the user to maintain instrument details, vendor details, service contracts, spare parts, maintenance, qualification and calibration details, etc. Ocimum developed flexible workflow engine to map diversified workflows being used by the customer in the organization. Ocimum designed and developed a project design module, which allows the user to design the requirements for synthesis of new custom formulated and synthesis materials. Ocimum provided project templates option to re-use the projects designed. 5

6 Ocimum provided flexible Batch Management, which aids the user in initiating and managing batch production of the formulated products and synthesis materials. Ocimum provided extensive query based inbuilt Report Engine, which allows the user to generate customized reports. Reports for MSDS, scheduling, inventories, batches, and instrument qualification and calibration were customized as per customer s specifications. Ocimum provided a extensive COA Report Configuration and Report Generation module. User can configure the format, details of product and raw materials specifications and results of analytical verification testing. Ocimum provided the option of auto scheduling batches and experiments with comprehensive graphical view of the batch and experiment schedules. Ocimum provided a solution to mark Quality Control test results and products as Out of Specification. Pharmatracker allows the user to define the specifications for different analyses. The observed values from an analysis are compared and validated with the specifications. Based on the comparisons, the products or synthesis materials are marked as Out of Specification or Non-conforming products or materials. Ocimum developed Quality Control Module, which allows the user to perform Quality Control tests on all inventory and results of tests conducted in the laboratory. Ocimum developed Instrument Interfacing and Automatic Data Capture for HPLC, GC, GC- MS, and LC-MS instruments. The system also performs statistical analysis on the raw data files captured into the system. Ocimum provided Statistical Analysis tools for performing Standard analysis, Purity analysis, Assay analysis, GC FID Head space analysis, Karl Fischer analysis, etc. Ocimum provided Budget Details, which facilitates the user to define the expected budgets and actual budgets. The system will calculate variance and generate budget reports. Ocimum provided the additional investigation feature, which allows customer to reopen a batch and perform additional investigations or experiments on the batch on receiving a complaint from the customer. 6

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